Karamzad Nahid, Faraji Esmaeil, Adeli Shaghayegh, Carson-Chahhoud Kristin, Azizi Samaneh, Pourghassem Gargari Bahram
Student Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran.
Department of Biochemistry and Diet Therapy, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.
Diabetes Metab Syndr Obes. 2020 Jun 26;13:2239-2249. doi: 10.2147/DMSO.S253014. eCollection 2020.
Type 2 diabetes mellitus (T2DM) is a prevalent disorder which accounts for 90-95% of diabetic patients. The aim of this study was to assess the effects of menaquinone (MK-7) supplementation on glycemic indices, anthropometric indices and lipid profile, among patients with T2DM.
In this double-blind placebo-controlled randomized clinical trial, 60 men and women with T2DM were allocated equally into either the MK-7 (200 µg/day) or the placebo group. Physical activity level and dietary intake were assessed using the international physical activity questionnaire-short form (IPAQ-SF) and a 3-day food record, pre- and post-intervention. Anthropometric measures, blood pressure, glycemic indices and lipid profile including fasting blood sugar (FBS), hemoglobin A1c (HBA1C), fasting insulin (FI), homeostatic model assessment insulin resistance index (HOMA-IR), triglycerides (TG), total cholesterol (TC), high-density lipoprotein (HDL-C) and low-density lipoprotein (LDL-C) were measured at baseline and after twelve weeks.
Forty-five patients completed the trial. There were no significant between-group differences for calorie intake, macronutrient intake, physical activity level or anthropometric measures at baseline and at the end of the study. Dietary vitamin K intake increased significantly at the end of the study in the MK-7 (: 0.02) and placebo (: 0.001) groups, but intergroup differences were not significant (: 0.86). FBS (: 0.01), HbA1c (p: 0.002), fasting insulin (: 0.01) and HOMA-IR (: 0.007) decreased significantly in the MK-7 group. Furthermore, after adjustment for the baseline values and changes of vitamin K intake at the end of study, FBS and HbA1C showed significant intergroup changes, and they were significantly lower in the MK-7 group compared to the placebo group. Lipid profile (TG, TC, LDL-C, HDL-C and LDL-C/HDL-C) did not change significantly within or between groups.
MK-7 supplementation seems to be effective in the improvement of glycemic indices, but not the lipid profile of patients with T2DM.
The present study was prospectively registered at the Iranian Registry of Clinical Trials on May 2019 (ID: IRCT20100123003140N22).
2型糖尿病（T2DM）是一种常见疾病，占糖尿病患者的90 - 95%。本研究的目的是评估补充甲萘醌（MK - 7）对T2DM患者血糖指标、人体测量指标和血脂谱的影响。
在这项双盲安慰剂对照随机临床试验中，60名T2DM男性和女性被平均分为MK - 7组（200μg/天）或安慰剂组。在干预前后，使用国际体力活动问卷简表（IPAQ - SF）和3天食物记录评估体力活动水平和饮食摄入量。测量基线及12周后的人体测量指标、血压、血糖指标和血脂谱，包括空腹血糖（FBS）、糖化血红蛋白（HBA1C）、空腹胰岛素（FI）、稳态模型评估胰岛素抵抗指数（HOMA - IR）、甘油三酯（TG）、总胆固醇（TC）、高密度脂蛋白（HDL - C）和低密度脂蛋白（LDL - C）。
45名患者完成了试验。在基线和研究结束时，两组在热量摄入、宏量营养素摄入、体力活动水平或人体测量指标方面没有显著的组间差异。在研究结束时，MK - 7组（P = 0.02）和安慰剂组（P = 0.001）的膳食维生素K摄入量均显著增加，但组间差异不显著（P = 0.86）。MK - 7组的FBS（P = 0.01）、HbA1c（P = 0.002）、空腹胰岛素（P = 0.01）和HOMA - IR（P = 0.007）显著降低。此外，在对基线值和研究结束时维生素K摄入量的变化进行调整后，FBS和HbA1C显示出显著的组间变化，MK - 7组显著低于安慰剂组。血脂谱（TG、TC、LDL - C、HDL - C和LDL - C/HDL - C）在组内或组间均无显著变化。
补充MK - 7似乎对改善T2DM患者的血糖指标有效，但对血脂谱无效。
本研究于2019年5月在伊朗临床试验注册中心进行了前瞻性注册（编号：IRCT20100123003140N22）。
